Effectiveness of Microwave Ablation of Hepatocellular Carcinoma as Compared to Radiofrequency Ablation
Recruitment status was: Recruiting
The purpose of this study is to compare microwave ablation using the Acculis Microwave Tissue Ablation (MTA) System with conventional radiofrequency ablation (RFA) using Covidien cool-tip radiofrequency needle in patients with localized unresectabe hepatocelluar carcinoma (HCC).
The investigators hypothesize that microwave ablation can achieve a better complete ablation rate as compared to radiofrerquency ablation.
A randomized comparative study is performed by randomly assigned participants to microwave ablation arm or radiofrequency ablation arm. The efficacy of treatment outcome is assessed by the complete tumor ablation rate at 1 month, recurrence rate and survival time of participants. Safety of the procedures is also compared between the 2 treatment arms.
|Hepatocellular Carcinoma||Procedure: Microwave ablation Procedure: Radiofrequency ablation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Microwave Versus Radiofrequency Ablation for Hepatocellular Carcinoma: a Prospective Randomized Control Trial|
- Complete ablation rate [ Time Frame: 1 month ]Measure by post-ablation Computed Tomography (CT) with reference to alpha-fetoprotein (AFP)
- Treatment related mortality [ Time Frame: 30-day ]
- Recurrent disease [ Time Frame: 3 year ]It is defined as the imaging detected new lesions
- Survival [ Time Frame: 3 year ]Overall and disease-free survival
- Long-term liver function [ Time Frame: 3 year ]Monitoring of liver function test result and the occurrance of decompensated cirrhosis
- Treatment related morbidity [ Time Frame: 30-day ]
- Hospital stay [ Time Frame: 30-day ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Procedure: Microwave ablation
Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
|Active Comparator: Radiofrequency||
Procedure: Radiofrequency ablation
Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340105
|Contact: Kit-fai Lee, MBBS||(852) email@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, China|
|Contact: Kit-fai Lee, MBBS (852) 26321411 firstname.lastname@example.org|
|Principal Investigator: Kit-fai Lee, MBBS|
|Principal Investigator:||Kit-fai Lee, MBBS||Division of Hepato-biliary and Pancreatic Surgery, Department of Surgery, The Chinese University of Hong Kong|